Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts

Stopped early · Phase 2

Conditions studied: End Stage Renal Disease

In brief

The purpose of this study is to establish the substantial equivalence of Expedial and ePTFE grafts for effectiveness in maintaining primary or assisted primary patency.

Key facts

Study ID

NCT00131872

Run by

LeMaitre Vascular

People needed

172

Starts

2004-03-01

Expected to finish

2006-11-01

Last updated by the study team

2024-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has chronic renal failure and requires vascular access for hemodialysis
• Patient has given informed consent to participate in the trial and is willing to comply with the study protocol
• Patient is male or female, 18 years of age or older
• The vascular access graft can be placed in the upper extremity (forearm, including across the elbow, or upper arm)
• Patient is undergoing or will undergo hemodialysis at a hospital or hemodialysis center
• Patient has a vein 4 mm or larger to which the graft can be anastomosed

You may not qualify if…

• Patient is unable to comply with the study follow-up
• Patient has a known sensitivity to polyurethane or porcine heparin
• Patient has a previous vascular access graft implanted and it is not possible to place the study graft proximal to the existing device and no other sites are available
• Patient has an immunodeficiency syndrome
• Patient has a prior history of bacterial infection within 8 weeks of implantation of graft
• Patient has a severe coagulation disorder
• Patient has an elevated platelet count of greater than 1 million
• Patient has a history of heparin-induced thrombocytopenia syndrome (HIT)
• Patient is pregnant
• Patient has a fever greater than 100 degrees Fahrenheit

Where it is running

• Vascular and General Surgery — Miami, Florida, United States
• Vascular Surgery Associates — Baton Rouge, Louisiana, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Vascular Surgery — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• General Surgery — Bamberg, South Carolina, United States
• South Carolina Associates for Cardiac and Vascular Disease; Greenville Hospital System — Greenville, South Carolina, United States
• Peripheral Vascular Associates — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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